Abstract

The importance of preventing and treating incomplete data in effectiveness studies is nowadays emphasized. However, most of the publications focus on randomized clinical trials (RCT). One flexible technique for statistical inference with missing data is multiple imputation (MI). Since methods such as MI rely on the assumption of missing data being at random (MAR), a sensitivity analysis for testing the robustness against departures from this assumption is required. In this paper we present a sensitivity analysis technique based on posterior predictive checking, which takes into consideration the concept of clinical significance used in the evaluation of intra-individual changes. We demonstrate the possibilities this technique can offer with the example of irregular longitudinal data collected with the Outcome Questionnaire-45 (OQ-45) and the Helping Alliance Questionnaire (HAQ) in a sample of 260 outpatients. The sensitivity analysis can be used to (1) quantify the degree of bias introduced by missing not at random data (MNAR) in a worst reasonable case scenario, (2) compare the performance of different analysis methods for dealing with missing data, or (3) detect the influence of possible violations to the model assumptions (e.g., lack of normality). Moreover, our analysis showed that ratings from the patient's and therapist's version of the HAQ could significantly improve the predictive value of the routine outcome monitoring based on the OQ-45. Since analysis dropouts always occur, repeated measurements with the OQ-45 and the HAQ analyzed with MI are useful to improve the accuracy of outcome estimates in quality assurance assessments and non-randomized effectiveness studies in the field of outpatient psychotherapy.

Highlights

  • Missing data that occur if patients drop out, either from the treatment or from the whole study, are a serious source of bias in the evaluation of treatment effectiveness

  • Assessing the Predictive Value of Outcome Questionnaire-45 (OQ-45) and Helping Alliance Questionnaire (HAQ) The analyses focused on two main questions:

  • It is apparent that already with a missing rate just under 20% CC produced in all settings point estimates affected by an amount of bias of more than 10%

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Summary

Introduction

Missing data that occur if patients drop out, either from the treatment or from the whole study, are a serious source of bias in the evaluation of treatment effectiveness. Effectiveness studies of psychotherapy are observational (Rosenbaum, 2010) and focus on external validity: data collection is carried out in a practice setting, patients are not randomized between different treatment conditions, and a rigorous treatment manual is not imposed to the therapists who can freely adapt their interventions to the needs of their patients (Seligman, 1995; Westbrook and Kirk, 2005). The topic of inference with missing data have been extensively researched in RCT, primarily conceived for testing pharmaceutical drugs (Little et al, 2012; Mallinckrodt, 2013). This knowledge can only be partially transferred to effectiveness studies of psychotherapy due of two peculiarities: the flexible length of the treatment and the lack of a control group

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